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Careers
Title: Manager of Regulatory Affairs
Reports to: Director of Regulatory Affairs
Direct Reports: None
Key Objective: Execute the regulatory strategy for Macropore submissions and prepare appropriate files for certifications of new products in the US, Europe and other foreign countries. Assure labeling is in compliance with regulations and existing regulatory clearances.
Responsibilities:
- Prepare and submit applications for new product clearance with FDA via the 510K process.
- Prepare and submit applications for experimental product exemptions with FDA via the IDE process.
- Prepare and submit applications for new products with FDA via the PMA process.
- Review product labeling, instructions for use, and promotional literature for regulatory compliance.
- Prepare and submit applications for new product approvals with EC (European Community) via the Design Dossier process.
- Prepare and submit applications for new product approvals with EC (European Community) via the Technical File process.
- Prepare and submit applications for new product approvals with Asian, Middle Eastern, South American, African, and Australian countries.
- Prepare and submit applications for new product approvals.
Position Requirements:
- Education - Bachelors degree in chemistry or life sciences
- 4-8 years of Regulatory Experience with Medical Devices
- 8-10 years of Medical Device Experience
- 2-4 years of CE Mark experience (Medical Device Directive)
- International regulatory experience a plus
E-mail resume to .
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